Implementation of a Self-Help Depression Program Among Orthopedic Patients

NCT ID: NCT03083340

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-08-01

Brief Summary

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The proposed study addresses the potential utility of providing an accessible self-help intervention for patients in a medical setting with an estimated diagnosis of MDD. Specifically, the study will explore whether a) such an intervention can be effectively implemented in a primary care setting and b) patients originally seeking medical attention for an orthopedic problem will be willing to seek psychological treatment and, c) improvement in depression symptoms will lead to improvement in upper and lower extremity functioning.

Detailed Description

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The present project will be an open-label trial to assess the feasibility and acceptability of a self-help intervention among a sample of orthopedic patients. In addition to monitoring the effectiveness of the Deprexis program on depressive symptoms, the proposed project will assess whether a reduction in depressive symptoms will be associated with improvement on patient reported orthopedic impairment. The investigators will enroll 50 adults and the participants will be given the opportunity to participate in 8 weeks of the web-based online Deprexis program.

Conditions

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MDD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Deprexis consists of 10 content modules representing different psychotherapeutic approaches, plus one introductory and one summary module, each of which can be completed in 10 to 60 minutes, depending on the user's reading speed, interest, motivation, and individual path through the program (Meyer, et al., 2009).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deprexis

Participants will complete 8 weeks of online treatment via a web-based program, Deprexis.

Group Type EXPERIMENTAL

Deprexis

Intervention Type BEHAVIORAL

Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.

Interventions

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Deprexis

Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All patients older than 18 years who present to a surgeon with an upper or lower extremity injury or disability at a participating center (see attached list)
* A level of clinical depression more than minimal symptoms as defined by a score ≥ 10 on the Patient Health Questionnaire-9 (PHQ-9)
* Willing and able to provide informed consent and comply with the protocol

Exclusion Criteria

* Injury or illness best treated with prompt surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2016-08-0089

Identifier Type: -

Identifier Source: org_study_id

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